Breast Cancer Drug OK’d 2 Months Ahead of Goal Date

Two months ahead of its user fee review goal, FDA has approved Puma Biotechnology’s Nerlynx (neratinib) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. An FDA release says the review used an “Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.”

Approval is based on data from the NALA (NCT01808573) trial, which involved 621 patients with metastatic HER2-positive breast cancer. The primary efficacy outcome measures were progression-free survival (PFS) and overall survival (OS). Median PFS was 5.6 months (95% CI: 4.9, 6.9) for patients who received neratinib with capecitabine and 5.5 months for those receiving lapatinib with capecitabine. Median OS was 21 months for patients receiving neratinib with capecitabine compared to 18.7 months for those receiving lapatinib plus capecitabine.